Anchor delivery system

ABSTRACT

A system and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device configured to deploy and implant anchor devices for such purposes.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of: 1) copending U.S. patentapplication Ser. No. 12/512,674, filed Jul. 30, 2009 which claims thebenefit of Provisional Application Ser. No. 61/084,937; 2) copendingU.S. patent application Ser. No. 11/775,162, filed Jul. 9, 2007: 3)copending U.S. patent application Ser. No. 11/671,914, filed Feb. 6,2007; 4) copending U.S. patent application Ser. No. 11/492,690, filed onJul. 24, 2006; 5) copending U.S. patent application Ser. No. 11/833,660filed on Aug. 3, 2007, which is a continuation of U.S. patentapplication Ser. No. 11/318,246, filed on Dec. 20, 2005; and 6)copending U.S. patent application Ser. No. 11/838,036 filed on Aug. 13,2007, which is a continuation of U.S. patent application Ser. No.11/134,870 filed on May 20, 2005; the entire disclosures of each ofwhich are expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods,and more particularly to systems and associated methods for manipulatingor retracting tissues and anatomical or other structures within the bodyof human or animal subjects for the purpose of treating diseases ordisorders and/or for cosmetic or reconstructive surgery or otherpurposes.

BACKGROUND

There are a wide variety of situations in which it is desirable to lift,compress or otherwise reposition normal or aberrant tissues oranatomical structures (e.g., organs, ligaments, tendons, muscles,tumors, cysts, fat pads, etc.) within the body of a human or animalsubject. Such procedures are often carried out for the purpose oftreating or palliating the effects of diseases or disorders (e.g.,hyperplasic conditions, hypertrophic conditions, neoplasias, prolapses,herniations, stenoses, constrictions, compressions, transpositions,congenital malformations, etc.) and/or for cosmetic purposes (e.g., facelifts, breast lifts, brow lifts, etc.) and/or for research anddevelopment purposes (e.g., to create animal models that mimic variouspathological conditions). In many of these procedures, surgicalincisions are made in the body and laborious surgical dissection isperformed to access and expose the affected tissues or anatomicalstructures. Thereafter, in some cases, the affected tissues oranatomical structures are removed or excised. In other cases, variousnatural or man made materials are used to lift, sling, reposition orcompress the affected tissues.

Benign Prostatic Hyperplasia (BPH)

One example of a condition where it is desirable to lift, compress orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffect men, especially elderly men. It has been reported that, in theUnited States, more than half of all men have histopathologic evidenceof BPH by age 60 and, by age 85, approximately 9 out of 10 men sufferfrom the condition. Moreover, the incidence and prevalence of BPH areexpected to increase as the average age of the population in developedcountries increases.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner region of theprostate gland to squeeze the urethra. This pressure on the urethraincreases resistance to urine flow through the region of the urethraenclosed by the prostate. Thus the urinary bladder has to exert morepressure to force urine through the increased resistance of the urethra.Chronic over-exertion causes the muscular walls of the urinary bladderto remodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate etc.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine etc.) thatcause urinary retention especially in men with prostate enlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Surgical procedures for treating BPH symptoms include TransurethalResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

The most effective current methods of treating BPH carry a high risk ofadverse effects. These methods and devices either require general orspinal anesthesia or have potential adverse effects that dictate thatthe procedures be performed in a surgical operating room, followed by ahospital stay for the patient. The methods of treating BPH that carry alower risk of adverse effects are also associated with a lower reductionin the symptom score. While several of these procedures can be conductedwith local analgesia in an office setting, the patient does notexperience immediate relief and in fact often experiences worse symptomsfor weeks after the procedure until the body begins to heal.Additionally all device approaches require a urethral catheter placed inthe bladder, in some cases for weeks. In some cases catheterization isindicated because the therapy actually causes obstruction during aperiod of time post operatively, and in other cases it is indicatedbecause of post-operative bleeding and potentially occlusive clotformation. While drug therapies are easy to administer, the results aresuboptimal, take significant time to take effect, and often entailundesired side effects.

Urinary Incontinence (UI)

Many women experience loss of bladder control following childbirth or inold age. This condition is broadly referred to as urinary incontinence(UI). The severity of UI varies and, in severe cases, the disorder canbe totally debilitating, keeping the patient largely homebound. It isusually associated with a cystocele, which results from sagging of theneck of the urinary bladder into or even outside the vagina

The treatments for UI include behavioral therapy, muscle strengtheningexercises (e.g., Kegel exercises), drug therapy, electrical stimulationof the pelvic nerves, use of intravaginal devices and surgery.

In severe cases of UI, surgery is generally the best treatment option.In general, the surgical procedures used to treat UI attempt to lift andsupport the bladder so that the bladder and urethra are returned totheir normal positions within the pelvic cavity. The two most commonways of performing these surgeries is through incisions formed in theabdominal wall or through the wall of the vagina.

A number of different surgical procedures have been used to treat UI.The names for these procedures include the Birch Procedure,Marshall-Marchetti Operation, MMK, Pubo-Vaginal Sling, Trans-VaginalTape Procedure, Urethral Suspension, Vesicourethral Suspension. Theseprocedures generally fall into two categories, namely a) retropubicsuspension procedures and b) sling procedures.

In retropubic suspension procedures, an incision is typically made inthe abdominal wall a few inches below the navel and a network ofconnectors are placed to support the bladder neck. The connectors areanchored to the pubic bone and to other structures within the pelvis,essentially forming a cradle which supports the urinary bladder.

In sling procedures, an incision is typically made in the wall of thevagina and a sling is crafted of either natural tissue or synthetic(man-made) material to support the bladder neck. Both ends of the slingmay be attached to the pubic bone or tied in front of the abdomen justabove the pubic bone. In some sling procedures a synthetic tape is usedto form the sling and the ends of the synthetic tape are not tied butrather pulled up above the pubic bone.

The surgeries used to treat UI are generally associated with significantdiscomfort as the incisions heal and may require a Foley or supra-pubicurinary catheter to remain in place for at least several days followingthe surgery. Thus, there exists a need in the art for the development ofminimally invasive (e.g., non-incisional) procedures for the treatmentof UI with less postoperative discomfort and less requirement forpost-surgical urinary catheterization.

Cosmetic or Reconstructive Tissue Lifting and Repositioning

Many cosmetic or reconstructive surgical procedures involve lifting,compressing or repositioning of natural tissue, natural tissue orartificial grafts or aberrant tissue. For example, surgical proceduressuch as face lifts, brow lifts, neck lifts, tummy tucks, etc. havebecome commonplace. In many cases, these procedures are performed bycreating incisions through the skin, dissecting to a plane beneathmuscles and fascia, freeing the muscles, fascia and overlying skin fromunderlying structures (e.g., bone or other muscles), lifting orrepositioning the freed muscles, fascia and overlying skin and thenattaching the repositioned tissues to underlying or nearby structures(e.g., bone, periostium, other muscles) to hold the repositioned tissuesin their new (e.g., lifted) position. In some cases excess skin may alsobe removed during the procedure.

There have been attempts to develop minimally invasive devices andmethods for cosmetic lifting and repositioning of tissues. For example,connector suspension lifts have been developed where one end of astandard or modified connector thread is attached to muscle and theother end is anchored to bone, periostium or another structure to liftand reposition the tissues as desired. Some of these connectorsuspension techniques have been performed through cannulas or needlesinserted through relatively small incisions of puncture wounds.

There remains a need for the development of new devices and methods thatcan be used for various procedures where it is desired to lift,compress, support or reposition tissues or organs within the body withless intraoperative trauma, less post-operative discomfort and/orshorter recovery times. Further, there is a need for an apparatus andrelated method which is simple to manufacture while simple to use.Various refinements in approach have been found beneficial to ensurereliable assembly of tissue anchor components, including approaches toavoid interference between moving parts. Structures ensuring propertiming of steps in an interventional procedure have also been found tobe beneficial as well as the proper alignment of component partsintended for implant. Additionally, operational guides which aid anoperator in properly orienting the medical device are beneficial.

The present disclosure addresses these and other needs.

SUMMARY

Briefly and in general terms, the present invention is directed towardsan apparatus and method for deploying an anchor assembly within apatient's body. The apparatus of the present disclosure includes varioussubassemblies which are mobilized via an actuator or other manuallyaccessible structure. The operation of the subassemblies is coordinatedand synchronized to ensure accurate and precise implantation of ananchor assembly.

In one embodiment, the delivery device is embodied in a tissueapproximation assembly. The tool includes a case assembly enclosing ananchor delivery and assembly structure, a needle spool assembly and asuture spool assembly. Extending from the case assembly is a shaftassembly. Also, extending through the shaft assembly are a pusherassembly, a needle, and a cutter assembly. Operatively associated withthe needle spool and suture spool assemblies are a needle actuator and aneedle retraction actuator (e.g., a lever). An assembly actuator isoperatively associated with the anchor assembly structure. Safety lockand lock-out structures are also operatively associated with the needleactuator and assembly actuator. Activation of the needle actuatoraccomplishes the advancement of a needle assembly and a first componentof an anchor assembly attached to a connector member, to aninterventional site. Activation of the needle retraction actuatorwithdraws the needle assembly leaving the first component of the anchorassembly at the interventional site. Thereafter, manipulation of theassembly actuator results in lockingly engaging a second anchorcomponent with the connector member and cutting the connector memberbelow the second anchor component.

In one particular aspect, the present invention is directed towards adelivery device which accomplishes the delivery of a first or distalanchor assembly component at a first location within a patient's bodyand the delivery of a second or proximal anchor assembly component at asecond location within the patient. The device also accomplishesimparting tension during delivery to a connector to hold it whileattaching the proximal anchor in situ. The procedure can be viewedemploying a scope inserted in the device. Also, the delivery device canbe sized and shaped to be compatible inside a sheath in the range of 17to 24 F, preferably a 19 F sheath or smaller.

Additionally, in a contemplated embodiment of an anchor delivery system,actuating a needle deploy actuator results in a needle being advancedwithin a patient to an interventional site. Activating a needleretraction lever accomplishes the withdrawal of the needle anddeployment of a first anchor component of an anchor assembly at theinterventional site. Depression of a second actuator facilitates theincorporation of a second component into the anchor assembly and itsrelease at the interventional site. The anchor delivery system with itsactuators and lever provide for a single-handed, one operator deliveryof a distal anchor component and proximal anchor component spaced apartwith a connector member between them. Various locking and sequencingmechanisms are provided for both operational as well as safety reasons.

The present invention also contemplates a reversible procedure as wellas an anchor assembly with sufficient visibility when viewedultrasonically, by X-ray, MRI or other imaging modalities. In oneaspect, the implant procedure is reversible by severing a connector ofan anchor assembly and removing an anchor of the anchor assembly such asby removing a proximally placed anchor previously implanted in anurethra. Moreover, the anchor assemblies can be formed of structuressuch as those having increased density to thereby facilitate ultrasoundviewing or other imaging modalities.

The anchor assembly can be configured to accomplish approximating,retracting, lifting, compressing, supporting or repositioning tissuewithin the body of a human or animal subject. Moreover, the apparatusconfigured to deploy the anchor assembly as well as the anchor assemblyitself are configured to complement and cooperate with body anatomy.Further, the anchor assembly can be coated or imbedded with therapeuticor diagnostic substances, in particular Botulinum toxin, or a silver ioncoating or such substances can be introduced into or near aninterventional site by the anchor deployment device or other structure.

In one embodiment, the anchor delivery device includes a handle assemblywith an actuator attached thereto. The actuator is associated with abody of the handle assembly and is operatively attached to the needleand structure that advances the first anchor member. A second actuatoris operatively associated with structure that accomplishes assemblingthe second anchor member to the connector member. Additionally, thehandle assembly is equipped with structure that is configured in onecontemplated embodiment, to effect the cutting of the connector memberand deployment of the first anchor member, second anchor member, andconnector at an interventional site.

In a specific embodiment, the anchor delivery device includes agenerally elongate tubular housing assembly member extending distallyfrom a handle assembly including an actuator. The proximal end of thehandle assembly is equipped with mounting structure configured toreceive a telescope or other endoscopic viewing instrument. A bore sizedto receive the telescope extends distally through a body of the handleassembly and continues through an outer tubular cover member forming thegenerally elongate member. Housed within the tubular housing assemblyare a telescope tube having an interior defining a distal section of thebore sized to receive the telescope, an upper tubular member assemblysized to receive at least one component of the implant assembly inside aneedle, and a lower tubular member assembly sized to receive at leastone second component of the implant assembly above a cutter member. Alocking member is provided to releasably lock the scope to the handleassembly.

Moreover, various alternative methods of use are also contemplated. Thatis, in some applications of the invention, the invention is used toimprove flow of a body fluid through a body lumen, modify the size orshape of a body lumen or cavity, treat prostate enlargement, treaturinary incontinence, support or maintain positioning of a tissue, closea tissue wound, organ or graft, perform a cosmetic lifting orrepositioning procedure, form anastomotic connections, and/or treatvarious other disorders where a natural or pathologic tissue or organ ispressing on or interfering with an adjacent anatomical structure. Also,the invention has a myriad of other potential surgical, therapeutic,cosmetic or reconstructive applications, such as where a tissue, organ,graft or other material requires approximately, retracting, lifting,repositioning, compression or support.

In one or more embodiments, the disclosed device can have a compactshaft profile which, for example, can fit into a 19 F cystoscopic sheathfor patient tolerant access during a procedure in which the patient isawake and lightly sedated. Optionally, the sheath can have an atraumaticterminal end made from translucent material for improving visibility ofthe distal end of the device. The device has a stiff distal shaft toallow manual compression of tissue with the bottom of the distal end ofthe shaft at an interventional site by means of leveraging or pushingthe tool handle. In a specific application, a spring-driven needle canbe deployed out of the bottom of the distal end of the shaft to a singledepth, to pierce through a predominate population of urethral-prostaticdistances. A spring driven deployment of the needle through the anatomyis used to pierce reliably with sufficient force and speed. In oneparticular approach, the needle has a beveled terminal end with a radiusapproximating the profile of the connector of the anchor assembly so asto avoid interference between the needle and connector during deliveryand assembly of the anchor assembly.

Further, the device can be configured with connector (e.g., suture)guides which provide centering of the connector and/or a stop to holdthe connector stable while an anchor is placed on it to ensure reliableassembly. In one embodiment, the cutter includes spacing structure toprovide minimal length of severed connector material adjacent the anchorcomponent after cutting. A shaft cover is also included to facilitateproper positioning of a connector and an anchor component during anchorassembly. A cutter assembly is further provided to sever a connectorbelow the anchor component subsequent to assembly of the anchorcomponent to the connector. The cutter assembly can include structurefor orienting a connector with respect to an anchor component as well asproviding the cutter with column strength.

Additionally, an automated tensioning spring is provided for actuationduring lever retraction, thus providing suture tension during the anchordeployment and making the anchor seating reliable, as well as minimizingthe distance between the two anchors and holding the target tissueapproximated. Also, a delivery tool shaft lumen has one or more surfacesto properly align the anchors to be registered with the tensionedsuture. Actuation of a final trigger can then translate a pusher elementto advance the anchor onto the suture with sufficient speed and force toseat with reliable retention force.

Other features and advantages of the present invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a left side view, depicting one embodiment of an anchordelivery system;

FIG. 2 is a perspective view, depicting the anchor delivery system ofFIG. 1;

FIG. 3 is a right side view, depicting the anchor delivery system ofFIG. 1;

FIG. 4 is a side view, depicting the anchor delivery system of FIG. 3with a portion of the casing removed and including a scope;

FIG. 5 is a left side view, depicting the anchor delivery device of FIG.1 with a portion of the casing removed and including a scope;

FIG. 6 is an exploded view, depicting components of a distal anchordelivery assembly;

FIG. 7 is an enlarged view, depicting a proximal portion of the needleassembly attached to the needle drive spool assembly;

FIG. 8 is a perspective view, depicting further details of the connectordepicted in FIG. 7;

FIG. 9 is an enlarged view, depicting a distal terminal end of a needleassembly;

FIG. 10 is an enlarged rotated view, depicting further details of theneedle of FIG. 9;

FIG. 11 is a side view, depicting a distal component and connector of ananchor assembly;

FIG. 12 is an enlarged side view, depicting a proximal terminal end ofthe connector of FIG. 11;

FIG. 13 is an enlarged view, depicting a connection between the proximalterminal end of the connector on a spool assembly;

FIG. 14 is a cross-sectional view, depicting a first step involving aninterventional procedure;

FIG. 15A is a perspective view partially in cross-section, depicting adistal terminal end of a delivery device;

FIG. 15B is a schematic representation approximately in coronel plane,illustrating the angling of the anchor delivery tool within anatomy;

FIG. 15C is an enlarged view, depicting proper placement of treatmentstructure against tissue anatomy;

FIGS. 16-19 are side views, depicting unlocking and depression of anactuator of a delivery device;

FIGS. 20 A-B are views of selected internal components of the deliverydevice, depicting action of the needle and connector spools of adelivery device;

FIG. 21 is a perspective view in partial cross-section, depictingpartial ejection of a needle assembly;

FIG. 22 is a perspective view in partial cross-section, depictingadvancement of a needle assembly;

FIG. 23 is a cross-sectional view, depicting advancement of a needleassembly at an interventional site;

FIGS. 24A-C are perspective and partial cross-sectional views, depictingan alternative approach to a needle assembly;

FIGS. 25A-B are partial cross-sectional views, depicting further detailsconcerning action of internal components of a delivery device uponactuation of a lever assembly;

FIG. 26 is a perspective partial cross-sectional view, depictingwithdrawal of a needle assembly leaving a connector element;

FIG. 27 is a cross-sectional view, depicting delivery of a firstcomponent of an anchor assembly at an interventional site;

FIGS. 28 A-B are perspective and exploded views, depicting variouscomponents of a shaft assembly of the delivery device;

FIGS. 29-32 are perspective views, depicting components of oneembodiment of a shaft assembly;

FIGS. 33A-34 are perspective views, depicting embodiments of a terminalend of the delivery device;

FIGS. 35-37 are perspective views, depicting contemplated features of acover assembly;

FIG. 38 is a schematic view, depicting further orientation featurescontemplated for the delivery device;

FIGS. 39 and 40 are a perspective view and side view, depicting oneapproach to a sheath mount assembly and shaft seal assembly.

FIGS. 41 and 42 A-B are perspective views, depicting an alternativeapproach to a shaft seal assembly;

FIG. 43 is a perspective view, depicting structure defining a scopelock;

FIGS. 44-46 are perspective views, depicting features of one embodimentof a cutter assembly of the delivery device;

FIG. 47 is a cross-sectional view, depicting positioning of an anchorwithin the cutter assembly;

FIGS. 48-52 are various views, depicting further features of a cutterassembly;

FIGS. 53-55 are perspective views, depicting proximal end connectors ofthe cutter assembly;

FIGS. 56-57 are perspective views, depicting features of a suture guide;

FIGS. 58-60 are perspective views, depicting features of a pusherassembly;

FIGS. 61-62 are partial cross-sectional views, depicting action of thelever permitting subsequent use of the cutter assembly as viewed fromone side of the device;

FIGS. 63-64 are partial cross-sectional views, depicting action ofinternal components of an interlock assembly of the proximal anchoractuator as viewed from the opposite side relative to FIGS. 61-62;

FIGS. 65-67 are partial cross-sectional views, depicting action ofinterval components upon activation of the proximal anchor actuator asviewed from same side as FIGS. 61-62.

FIG. 68 is a cross-sectional view, depicting release of a second anchorcomponent within an interventional site;

FIG. 69 is a cross-sectional view, depicting release of an assembledanchor assembly within an interventional site;

FIG. 70 is a cross-sectional view looking along the axis of the urethrawithin an enlarged prostate, depicting an untreated interventional site;

FIG. 71 is a cross-sectional view looking along the axis of the urethrawithin an enlarged prostate, depicting implantation of two anchorassemblies at an interventional site;

FIG. 72 is an enlarged view of a portion of FIG. 71; and

FIG. 73 is a cross-sectional view, depicting another view of two anchorassemblies implanted at an interventional site.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the figures, which are provided by way of example and notlimitation, the present disclosure is directed to a device configured todeliver an anchor assembly within a patient's body. As stated, thedisclosed apparatus can be employed for various medical purposesincluding but not limited to retracting, lifting, compressing,approximating, supporting or repositioning tissues, organs, anatomicalstructures, grafts or other material found within a patient's body. Suchtissue manipulation is intended to facilitate the treatment of diseasesor disorders. Moreover, the disclosed invention has applications incosmetic or reconstruction purposes or in areas relating the developmentor research of medical treatments.

In an aspect of the present invention, one portion of an anchor assemblyor implant is positioned and implanted against a first section ofanatomy. A second portion of the anchor assembly or implant is thenpositioned and implanted adjacent a second section of anatomy for thepurpose of retracting, lifting, compressing, approximating, supportingor repositioning the second section of anatomy with respect to the firstsection of anatomy as well as for the purpose of retracting, lifting,compressing, approximating, supporting or repositioning the firstsection of anatomy with respect to the second section of anatomy. It isalso to be recognized that both a first and second portion of the anchorassembly can be configured to accomplish the desired retracting,lifting, compressing, approximating, supporting or repositioning ofanatomy due to tension supplied during delivery via a connector assemblyaffixed to the first and second portions of the anchor assembly orimplant.

Referring now to FIGS. 1-3, there is shown one embodiment of a device100. This device is configured to include structure that is capable ofboth gaining access to an interventional site as well as assembling andimplanting one or more anchor assemblies or implants within a patient'sbody. In one embodiment, the device 100 is configured to assemble andimplant a single anchor assembly or implant. The device is furthercontemplated to be compatible for use with a 19 F sheath. The deviceadditionally includes structure configured to receive a conventionalremote viewing device (e.g., an endoscope) so that the steps beingperformed at the interventional site can be observed.

Prior to use of the present device 100, a patient typically undergoes afive day regiment of antibiotics. A local anesthesia can be employed forthe interventional procedure. A combination of an oral analgesic with asedative or hypnotic component can be ingested by the patient. Moreover,topical anesthesia such as lidocaine liquids or gel can be applied tothe bladder and urethra.

The anchor delivery device 100 includes a handle assembly 102 connectedto an elongate tissue access assembly 104. The elongate tissue accessassembly 104 houses components employed to construct an anchor assemblyand is sized to fit into a 19 F cystosopic sheath for patient toleranceduring a procedure in which the patient is awake rather than undergeneral anesthesia. The tissue access assembly is stiff to allow manualcompression of tissue at an interventional site by leveraging or pushingthe handle assembly 102.

The anchor delivery device 100 further includes a number ofsubassemblies. A handle case assembly 106 including mating handle partswhich form part of the handle assembly 102. The handle assembly 102 issized and shaped to fit comfortably within an operator's hand and can beformed from conventional materials. Windows can be formed in the handlecase assembly 106 to provide access to internal mechanisms of the deviceso that a manual override is available to the operator in the event theinterventional procedure needs to be abandoned.

In one embodiment, the delivery device 100 is equipped with variousactivatable members which facilitate assembly and delivery of an anchorassembly at an interventional site. A needle actuator 108 is providedand as described in detail below, effectuates the advancement of aneedle assembly (loaded with a first component of an anchor assembly) toan interventional site. In a preferred embodiment, the needle assemblyhas a needle that moves through a curved trajectory and exits the needlehousing in alignment with a handle element, and in particularembodiments, in alignment with the grip. In various other embodiments,the needle housing is oriented such that the needles exits the housingat either the two o'clock or ten o'clock positions relative to a handlegrip that is vertical. A needle retraction lever assembly 110 is alsoprovided and when actuated causes the needle assembly to be withdrawnand expose the first anchor component. This action and the structureinvolved is also described in detail below. Finally, the delivery device100 is equipped with a rear or proximal anchor actuator assembly 112which as fully described below, upon actuation, accomplishes assembly ofa second component to the anchor assembly and release of the anchorassembly at the interventional site.

Turning now to FIGS. 4-5 in addition to FIGS. 1-3, a number of thesubassemblies of the delivery device 100 are introduced, the functionand structure of each of which are addressed in detail below. In theembodiment depicted, the case assembly 106 has three mating parts, aleft top case 114, a left bottom case 116, and a right case 118. It iswithin the scope of the present disclosure that the case assembly bemade of a variety of numbers of parts. In addition to mating to enclosesubassemblies, the case parts also include structural features forproviding rigidity and support for the enclosed components.

Housed within the case assembly 106 are a distal anchor deliverymechanism 119 including a needle spool assembly 120 and a suture spoolassembly 122 (referred to interchangeably herein as connector spoolassembly 122). The rotational axes of the needle spool assembly andsuture spool assembly are the same. A shaft assembly 124 includes aportion residing within the case assembly 106 and a portion extendingfrom a forward end of the case assembly. Attached to and operativelyassociated with the shaft assembly 124 is a proximal anchor driveassembly 126. The drive assembly 126 is also housed within the caseassembly 106. FIGS. 4 and 5 illustrate the juxtapositional relationshipsof the various subassemblies.

With reference to FIG. 6, details concerning an embodiment of thestructure of a distal anchor delivery mechanism 119 are presented. Asdescribed further below, the needle spool assembly 120 cooperates withthe needle actuator 108 and needle retraction lever 110 to advance andthen withdraw a needle assembly at an interventional site.

The needle spool assembly 120 is a generally disc-shaped structurehaving a number of landings and projections for engaging and receivingvarious structures of the distal anchor delivery mechanism 119.

A needle deploy spring 206 functions to rotate the needle spool 120(referred to interchangeable herein as connector spool 120) and toproject a tip of the needle through tissue with force and speed. One endof the deploy spring 206 is attached to the device casing and theopposite end is engaged with a shuttle 215. The shuttle 215, in turn, isoperatively and releasably associated with the needle spool assembly120. In one approach, it is contemplated that the device 100 beconfigured so that the needle is deployed to a single depth to piercethrough a predominant population of urethral-prostatic distances inpatients having an enlarged prostate.

The assembly further includes a needle deploy pawl 222 which isoperatively associated with the needle actuator 108. As shown anddescribed below, the needle actuator pivots the needle deploy pawl 222away from engagement with the needle spool assembly 120, therebypermitting rotation of the same. The rotation of the needle spoolassembly 120 is accomplished by forces generated by the deploy spring206.

An unsheathing pawl 224 is also provided and configured at one end toengage the needle spool 120. At another end of the unsheathing pawl 224there is structure configured to engage the suture spool assembly 122(described below) to thereby fix its rotational position while theneedle spool assembly 120 rotates. A tension spring 226 is positionedwithin a center bore of the suture spool 122 to provide tension to aconnector or suture projecting from the suture spool 122. A lever lockand tape 228 is also provided to lock the lever 110 until afteractuation of the needle actuator 108. The lever lock and tape 228 has acentral axis or rotating point which is common with that of the needlespool 120 and suture spool 122 assemblies and also functions to retracta needle assembly upon depression of the lever 110. Also shown in FIG. 6is the needle assembly 230.

As shown in FIGS. 7 and 8, a proximal end of a needle assembly 230 canbe sized and shaped for connecting with the needle spool 120. In oneapproach, the proximal end 232 of the needle assembly 230 is equippedwith a needle end bracket 234 for receipt within a corresponding recessformed near a periphery of the needle spool 120. Through suchconnections, rotation of the needle spool 120 can result in advancingand withdrawing lengths of a needle assembly. In this regard, as shownin FIG. 7, a peripheral recess formed in the needle spool 120 isprovided to take up lengths of a needle assembly. Further, a recess 236is formed in the needle end bracket 234 for guiding a proximal end of aconnector of an anchor assembly to within a channel 238 formed in theneedle spool 120. The needle spool channel 238 provides a path to thesuture spool 122 (as described below).

A distal end 240 of a generally tubular needle assembly 230 is shown inFIGS. 9 and 10. The distal end 240 defines a sharpened profile forpiercing through tissue. In one particular approach, the distal end 240embodies a 23° primary bevel geometry and a heal 242 of the bevel so asto closely match a 0.015″ diameter connector structure of an anchorassembly. In this way, potential snags between the connector structureand needle assembly can be minimized or avoided.

One form of a distal anchor 350 and connector member 352 of an anchorassembly is shown in FIG. 11. It is the proximal end of the connector352 which is fixed to the suture spool 122 by a ferrule 314 (See FIGS.12 and 13). An annular space formed about the suture spool 122 isprovided to receive a length of the pusher 354. The ferrule termination314 offers a secure and inexpensive method for attaching the connectorassembly 352 to the suture spool 122. The ferrule 314 can be easilypressed into receiving features of the spool assembly 122 and can bereadily removed after the device is test fired on the production line.In an alternative embodiment, the connector to the suture spool can alsodefine a plastic molded snap ferrule. In other alternative embodiments,the ferrule 314 can be replaced with an over molded component or anintegral feature such as a bump in the connector member 352.

In one particular, non-limiting use in treating a prostate (See FIG.14), the elongate tissue access portion 104 of a delivery device isplaced within a urethra (UT) leading to a urinary bladder (UB) of apatient. In one approach, the delivery device can be placed within anintroducer sheath (not shown) previously positioned in the uretha oralternatively, the delivery device can be inserted directly within theurethra. When employing an introducer sheath, the sheath can be attachedto a sheath mount assembly (described below). The patient is positionedin lithotomy. The elongate portion 104 is advanced within the patientuntil a leading end 400 thereof reaches a prostate gland (PG). In aspecific approach, the side(s) (i.e., lobe(s)) of the prostate to betreated is chosen while the device extends through the bladder and thedevice is turned accordingly. The device is first positioned at thebladder neck and then retracted approximately 1 cm while keeping thedevice parallel to the prostatic fossa and preserving mucosa. As shownin FIG. 15 A, when so placed, the distal end 240 of the needle assemblyis withdrawn within the leading end 400 of the device. The distal end ofthe elongate portion can be used to push the urethra into the prostategland. The inside of the prostate gland (i.e., adenoma) is spongy andcompressible and the outer surface (i.e., capsule) of the prostate glandis firm. By the physician viewing with the endoscope, he/she can pushthe urethra into the prostate gland compressing the adenoma and creatingthe desired opening through the urethra. To accomplish this, thephysician rotates the tool anterior between 9 and 10 o'clock for thepatient's side left lobe and between 2 and 3 o'clock for the patient'sside left lobe. The physician then pivots the tool laterally about thepubic symphysis PS, generally about 20 to 30 degrees relative to thepatient's midline (See FIG. 15B which depicts an image approximately incoronal plane). Viewing through the endoscope, the physician wants tohave about the same amount of tissue protruding on both sides of theelongate shaft (See FIG. 15C).

As shown in FIGS. 16 and 17, the delivery device is at this stageconfigured in a ready state. The needle actuator 108 and the needleretracting lever 110 are in an inactivated position. The needle actuator108 is locked by a pivoting safety mechanism 402 in an inactiveposition. To unlock the needle actuator (See FIGS. 18 and 19), thesafety mechanism 402 is rotated out of engagement with the needleactuator 108 by applying a lateral force on a projection of the safetymechanism 402.

Upon depression of the needle actuator 108 (FIG. 19), an upper end ofthe actuator 108 engages and rotates the needle deploy pawl 222 out fromengagement with the needle spool 120 (See FIGS. 20A and B). This actionovercomes the friction with needle spool 120. Disengagement of thedeploy pawl 222 from the needle spool 120, permits the needle deployspring 206 through its connection via the shuttle 215, to rotate theneedle spool 120. The needle spool 120 rotates until the unsheathingpawl 224 catches an external surface of the suture spool 122 and untilthe needle spool 120 bottoms out against the case 228. At the end of theneedle stroke, the lever lock and tape 228 becomes disengaged from theright case 118. The shuttle in this embodiment disengages from theneedle spool so the needle deploy spring 206 can no longer apply a forceto the needle spool 120 via the shuttle 215.

At the leading end 400 of the delivery device, as shown in FIGS. 21 and22, such action results in the needle assembly being advanced fromwithin the elongate member 104. As is to be appreciated, the needle isejected by the needle deploy spring 206 in this embodiment in adirection commensurate with the direction the handle assembly extends.Moreover, the needle assembly can be configured so that it curves backtoward the handle as it is ejected. In use in a prostate intervention(See FIG. 23), the needle assembly 230 is advanced through and beyond aprostate gland (PG). To facilitate the same, the device can be pivoted20° to 30° laterally (pivoting about pubic symphisis). Additionally, thedevice can be rotated anteriorly to lift a prostatic lobe (as describedpreviously). The spring deployment helps to ensure the needle tip passesswiftly through the tough outer capsule of the prostate without“tenting” the capsule or failing to pierce the capsule. In an alternateembodiment, the needle could be manually deployed by the user. In oneapproach, the needle 230 is made from Nitinol tubing and can be coatedwith Parylene N. Such a coating helps compensate for frictional orenvironmental losses (i.e. wetness) which may degrade effectiveness ofneedle penetration.

It is also contemplated that the needle assembly 230 can include anintegral tip and capsular anchor 231 which is releasably configurable ata distal end of the needle assembly 230 (See FIGS. 24A-C). Upon needleretraction, the tip-anchor 231 remains on an outside of a prostatecapsule. The tip-anchor 231 can have a solid tissue piercing surfaceproviding increased strength and structure for passing through tissue.Moreover, being configured to be released from a proximal length of theneedle assembly 230, such a proximal portion can assume a smallerdiameter since the capsular anchor 231 does not need to reside withinthe needle assembly 230. A smaller profile needle assembly can in turnlead itself to providing more flexibility in delivery apparatusstructure and aid in advancing the assembly to an interventional site.This approach also can avoid any interference which may occur with anapproach involving ejecting an anchor from within a hollow needle.Further, the tip-anchor 231 can include a slot 233 which facilitatesflipping of the anchor into a position on the outside of a prostatecapsule.

After complete depression of the needle actuator 108 and the unlockingof the needle retraction lever 110, the needle retraction lever 110 canbe actuated (See FIGS. 25A-B). When so actuated, the tape portion of thelever lock and tape 228 cooperates with the lever 110 to rotate theneedle spool 120 in an opposite direction while the suture spool 122 isheld stationary. Such action results in a withdrawal of the needleassembly 230, leaving the connector 352 of an anchor assembly in anextended position (See FIG. 26). In one embodiment, the needle 230 iswithdrawn further than its original position within the devicepre-deployment. When extended, the connector 352 extends through theneedle window and is centered by suture guide structure (as describedbelow). As shown in FIG. 27, in a prostatic interventional procedure,the same results in delivering a first or distal anchor componentattached to the connector 352 beyond an outer surface of a prostategland (PG) with the connector 352 within a penetration tract in theprostate gland extending toward the terminal end 400 of a deliverydevice.

The tensioning spring 226 provides the tension forces which helps toensure the distal anchor is pulled back into firm contact with a desiredtissue plane such as, for example, the outer capsular surface of theprostate gland (FIG. 25A). Notably, the spring in a preferred embodimentprovides a force such as up to 1-2 pounds or more of tension. In anotherembodiment, a spring can be used to automatically retract the needleassembly.

The timing of the needle retraction and tensioning is accomplishedthrough the interaction of the unsheathing pawl 224 and the suture spool122. As shown in FIGS. 20A-B, 24 and 25, the unsheathing pawl 224 isconfigured to permit a rotation of the suture spool 122 which occursduring needle actuator depression until the unsheathing pawl 224registers within grooves formed in the suture spool 122. Actuation ofthe needle retraction lever 110 causes a deflection of the unsheathingpawl 224 (See FIG. 25B) which disengages the unsheathing pawl 224 fromthe suture spool 122. Since the suture spool 122 is at this pointdisengaged from the operation of the spring arbor as described above,the suture spool 122 is permitted to rotate in an opposite direction.This rotation continues until the suture spool bottoms out on the needlespool 120. Complete depression of the lever 110 also then results in thelever locking against the case assembly 106. The tensioning spring 226is then left to automatically provide a consistent tensioning force on aconnector of an anchor assembly. Such tensioning results in seating adistal or first anchor component 350 as desired within an interventionalsite such as shown in FIG. 27 as well as to minimize a distance betweentwo anchor members of an implanted anchor assembly. The tensiongenerated after seating the anchor component 350 can be different fromthat during delivery of the connector of the anchor assembly.

A more detailed description of the shaft assembly now follows as does adescription of the operation of the structure achieving assembly of asecond or proximal anchor component to a connector of an anchor assemblyand release of a complete anchor assembly at the interventional site.

With reference to FIGS. 28A-B, there is shown an embodiment of a shaftassembly 124. Components of the shaft reside within the device caseassembly 106 and include structure attached to and cooperating withproximal anchor delivery and assembly structure. A terminal end portion400 of the shaft assembly 124 includes an atraumatic distal tip 502.Proximally located to the tip 502 is a tubular shaft assembly 504 whichis sized and shaped to slidably receive the needle assembly. An internalportion of the tip 502 is curved so that a needle projecting therefromextends in a direction generally corresponding to that of a handleelement of the delivery device. Configured longitudinally adjacent thetubular shaft assembly is a scope tube 506 which is sized and shaped toreceive a scope as described previously. Configured below andlongitudinally adjacent the scope tube 506 is an elongate cover 507which is sized to receive elongate portions of the cutter and pusherassemblies.

As shown in FIGS. 29-32, the shaft assembly 124 can alternatively beformed from modular pieces. For example, a telescope tube 506 can beemployed as a backbone about which a molded tip 502 and a shaftextension 509 are configured. An atraumatic tip sleeve 591 can be placedover the tip 502 and an elongate cover 507 can be placed longitudinallyalong the shaft extension 509. This modular shaft assembly permits theuse of injection molded components to form the shaft. Injection moldedcomponents are less expensive and can lead themselves to easy and quickassembly. Moreover, different materials can be chosen for the variousshaft components to thereby provide desired shaft stiffness. Further, inone contemplated approach, a clear sheath hood 515 can be configuredabout the distal tip 502 so that a matching of a sheath and a distalportion of the device can be better accomplished.

During use of the present device, viewing of the interventional site isaccomplished through a telescope which can involve a foreshorteningeffect in the field of view. In addition, because of the speed of theneedle and the end of the tool being pressed into the tissue and thelobes protruding on each side, the operator may not know or see wherethe needle assembly will exit the device and/or engage tissue.Therefore, a needle directing arrow 511 can be included on the tip 502.The distal tip 502 can also include indicators which facilitateproviding the operator with further orientation guides. In one approach(FIG. 33A), an indicator 513 can be placed on lateral projections of thetip 502. Another approach can involve an indicator 513 defining alaterally directed arrow 511 (See FIG. 33B). Thus, the tip indicator 513can be pushed directly against tissue to show where the needle will exitand subsequently where a proximal anchor will land. In yet anotherapproach (FIG. 34), a reflective surface 518 can be configured on thedistal tip 502 distal to where the connector exits the tip 502. In thisway, light can be reflected back onto the connector to thus light up thearea and improve visualization of the connector when the area is dark. Acircular, elliptical, parabolic or straight cut can be made and providedwith a reflective surface. These features can alternatively beincorporated into a cover assembly as a separate part or adhered to thecover with atraumatic tape or be part of the tap itself. The features insome embodiments take advantage of a light source associated with theviewing apparatus being employed and reflect light back providing abright appearance. The relatively perpendicular angle of the indicatorswith respect to the light source results in significant contrast. In oneembodiment, a small fiber optic resides in the shaft assembly, such asparallel to the cover on the outside or inside the cover parallel to thecutter, using the same light source as the endoscope/telescope. Thefiber can have a right angle output so that the light shines onto thetissue.

In another approach to providing the operator with orientation, asstated, the cover 507 can include indicators. As shown in FIGS. 35-37,the cover 507 can include indicators 513 on faces generallyperpendicular to the viewing orientation. It is to be noted that suchindicators can assume various shapes such as rectangles and arrows.

In a related approach (See FIG. 38), the present device can includevertical indicators 517 to aid in keeping a connector of the anchorassembly centered relative to a proximal anchor component duringassembly and delivery of the anchor assembly. There is a controlleddelay between the application of tension to a connector and the deliveryof a proximal anchor at an interventional site. During this delay, theconnector can potentially get off-center or move too far distal relativeto the proximal anchor component. The vertical lines 517 thus aid anoperator with manually guiding the connector into an optimal positionsuch as placing the connector parallel to or between the vertical lineindicators 517. The indicators can be formed from small wires runningvertically in the scope view distal of the scope and proximal of acentered connector position. The tip or cutter can also be modified toinclude such vertical lines formed for example, by etching.

With reference to FIGS. 39-40, at a proximal end of the shaft assembly124 is a sheath mount assembly 510 including a screw lock 512.Configured to extend through this structure are proximal portions of acutter assembly 514 and a pusher assembly 516. Both the cutter andpusher assemblies include elongate portions extending toward a distalend 400 of the shaft assembly 124. The screw lock 512 of the sheathmount assembly 510 can be screwed to a terminal end of an introducersheath assembly (not shown). The sheath mount 510 can include anelongate seal 519 (FIG. 40) which functions to seal and minimize fluidingress into the handle portion of a delivery device. A proximal end ofthe seal 519 includes a lateral extension 521 which engages a proximalsurface of the sheath mount to prevent the seal 519 from migratingdistally and potentially jamming or stalling the cutter or pusher. Inanother approach (FIGS. 41-42B), a disc-like seal 530 is configured tobe captured between the sheath mount 510 and case halves duringassembly. The seal 530 restricts the flow of fluids (i.e., saline orirrigation solution) through the cutter/pusher area via a thin wiperfeature. The seal 530 slightly compresses into the sheath mount 510 andis indexed over an outer profile of the shaft 124. The seal 530stretches over the shaft and has a 0.010 inch thick wiper element 532 atthe cutter/pusher interface to limit friction and reduce fluid flow.

As shown in FIG. 43, the scope mount screw lock assembly 508 (See alsoFIGS. 1-5) includes a screw lock 520 for mating with the casing of thepresent device and a central opening for receiving a scope 549 which hasa longitudinal dimension sufficient to extend longitudinallysubstantially a length of the scope tube 506. The central opening isshaped to lockingly receive the scope. The screw lock 520 includes twopairs of cantilevers 523 that form undersized gaps for tabs (not shown)formed on the device casing to press through. During use, the locks 520remain engaged with the tabs due to the gaps therebetween beingundersized. It is intended that the screw lock be configured so that thegap in the middle of the lock 520 places the weakest point of the lockin a position unlikely to be pulled on by the user or operator.

As best shown in FIGS. 44 and 45, an embodiment of the cutter assembly514 includes elongate cutter tube 562. A distal end 568 of the cuttertube 562 is configured with a blade 569 so that once the cutter assembly514 is withdrawn, the blade can sever as desired a connector of ananchor assembly. In one particular embodiment, the cutter 514 can beformed from ground 17-4PH stainless steel blank. Various structures arecontemplated for incorporation into the cutter assembly to facilitate aclean severing of a connector as well as to aid in assembling a proximalcomponent of an anchor assembly to the connector. For example, as bestseen in FIG. 45, the cutter blade 569 includes a coined out undersidethat is intended to be offset from a bottom side of a proximal anchor byabout 0.0035+0.0010 inches to cut a nominal 0.015 inch diameterconnector. In this way, the proximal anchor can exit a cutter withoutdeforming or compressing a suture or connector tag, and the strength ofthe connector to anchor connection is maintained.

As shown in FIGS. 46-48, the cutter 514 can define a generallyrectangular elongate single body that can be formed by stamping andbending. An interior of the body is sized and shaped to receive aproximal anchor component 550. A proximal end portion of the cutter 564can further include anti-buckling tabs 551 and extensions 553 intendedto snap fit to a cutter block (described below). Lance-out structures555 are also contemplated to be spaced along the cutter body whichfacilitate alignment of the cutter 514 within the shaft assembly.

To eliminate snagging of a connector, walls defining a needle window 557formed in the cutter 514 can be contoured to help properly guide theconnector into a suture capture area 559. As best seen in FIG. 49, aproximal portion of the needle window 557 defines a gradual slope fordirecting the connector within the capture area 559. In a relatedapproach (FIG. 50), bumps 561 can be formed on connector guidingstructure to further aid in properly positioning a connector 352 forengagement with a proximal anchor component 555.

Moreover, as depicted in FIGS. 51 and 52, the cutter 214 can furtherinclude skew limiting projections 563 extending internally within thegenerally tubular cutter 214. As best seen in FIG. 52, the projections563 help to maintain proper positioning of a proximal anchor component555 within the cutter 214.

Approaches to attaching the cutter 214 to a cutter block 565 are shownin FIGS. 53-55. As shown in FIG. 53, a point of potential buckling 567of the cutter assembly can coincide with its connection to a cutterblock 565. To offset such buckling, the anti-buckling tabs 551 can beconfigured adjacent a distal face of the cutter block 565 (FIG. 54).Such anti-buckling tabs 551 can alternatively or additionally be foldedat a 30° angle to help index the cutter with respect to the cutter block565. In each of these approaches, the extensions 553 snap fit toreceiving structures of the cutter block 565.

In a further aspect, the present device can include a suture alignmentslide 570 configured to slide under a cover 571 and over the cutter 514.The cover 571, in turn, includes a finger projector 573 which is sizedand shaped to control and guide the movement of a proximal anchor 555.The alignment slide 570 indexes the connector 352 to a centerline of thecutter 514. It also operates to pull the connector 352 proximally forindexing within the proximal anchor component 555 to thus enhanceconnector capture by the anchor component 555. In other embodiments, adistal end of the needle housing itself can alternatively oradditionally include a slot or notch for properly registering theconnectors during device use and particularly when tension is beingapplied to the connector.

In order to accomplish the attachment of the proximal anchor 555 to theconnector 352, a pusher assembly 575 is configured to extend within thecover 571 (See FIGS. 58-60). The pusher assembly 525 can include aproximal portion 577 which extends to the handle of the device(connected to pusher block as described below) and a distal portion 579which attaches to the proximal portion 577. The distal portion 579 canfurther include an extension 581 sized to receive the length of aproximal anchor 555. The thickness of the extension 581 is chosen toensure a 0.004 inch gap between a cutter and a bottom portion of theproximal anchor 555 so that a connector tag remains after its severingby the cutter. The cover 571 can further include an anchor stop 583which is configured at a distal end of the cover 571. The anchor stop583 is sized and shaped to protect the proximal anchor 555 from becomingtrapped within the cover 571 after its engagement with the proximalanchor 555.

Details of an embodiment of the proximal anchor drive assembly 126 aredepicted in FIGS. 61-67. The proximal anchor drive 126 includes thecutter block 565 operatively connected to a pusher block 604 by a spring606. Longitudinal motion of each of the cutter and pusher blocks 565,604 are guided by recesses formed in the casing 106 of the device. Acutter pawl 608 is further provided to control the timing of the actionof the cutter and pusher blocks 565, 604. Initially, the operation ofthe proximal anchor drive 126 is locked out by the lever 110 (FIG. 61)as well as the proximal anchor actuator assembly 112. Upon depression ofthe lever 110 as described above in connection with the retraction ofthe needle, the lever 110 is moved such that its engagement with thecutter pawl 608 is removed (FIG. 62). It is in this condition that theproximal anchor drive 126 can be activated once the proximal anchoractuator assembly 112 is unlocked.

The proximal anchor actuator assembly 112 is configured at a back end ofthe casing 106 and includes a pusher pawl 610 and a pusher pawlinterlock 612 (See FIGS. 63 and 64). The pusher pawl interlock 612 canbe unlocked by the retraction lever 110 away from engagement with thepusher pawl 610 to thereby unlock the proximal anchor drive 126. Next,the pusher pawl 610 can be rotated by the operator to activate theproximal anchor drive 126 (See FIGS. 65 and 66). By so rotating thepusher pawl 610, the pusher block 604 is released and the spring 606causes the pusher block 604 to slide forwardly. Through its connectionto the pusher of the pusher block 604, the pusher assembly 575 isadvanced distally which, in turn, results in the proximal anchorcomponent 555 engaging the connector 352 (See also FIG. 60).

Next, the pusher block 604 contacts a first end of the cutter pawl 608causing its second end to rotate away from the engagement with thecutter block 565. It is to be noted that the timing of first advancing aproximal anchor component 555 and then cutting a connector 352 to lengthcan be controlled by the force applied by the spring 606, the distancethe pusher block 604 is to travel, and/or the location of the first endof the cutter pawl 608. A proximal end of the cutter 214 is attached tothe cutter block 565. As the cutter block 565 moves proximally, thecutter 214 is withdrawn.

Accordingly, release of the pusher assembly advances the secondcomponent 555 of an anchor assembly into locking engagement with aconnector of an anchor assembly (See FIG. 60). Such action causes thepusher 575 to advance the anchor component 555 onto a connector (e.g., asuture) while the connector is being held by the tool with sufficientforce and the anchor is advanced with sufficient speed and force to seatthe anchor 555 with reliable retention force. Within a patient's body,as shown in FIG. 68, the anchor assembly is configured across anatomywithin the interventional site. Upon withdrawal of the cutter assembly,the blade portion thereof is brought across the connector 352 therebysevering it close to the second anchor component 555 leaving a shorttag. The resultant implanted anchor assembly 700 is shown in FIGS. 69,71 and 72. FIG. 71 depicts a partial cross-sectional view of the urethra(UT) widened due to the anchor assembly compressing the surroundingenlarged prostate tissue due to the fact that the outer capsular tissueis rather strong, substantially non-compressible and non-displaceablewhile the adenoma of the prostate gland is compressible and the urethralwall displaceable. By way of comparison, FIG. 70 depicts a partialcross-sectional view of an untreated interventional site of the urethra(UT) narrowed by the surrounding enlarged prostate tissue.

The second anchor component can be embodied in a slotted anchorconfigured to secure to a connector. The slotted proximal anchor caninclude a flattened-tubular back end that resembles a flattened tube inshape, with a width in lateral cross-section that is greater than itsthickness. The slotted proximal anchor also includes a pair of spacedapart prongs extending from the back end of the slotted proximal anchorto the front end of the slotted proximal anchor. The spaced prongs jointogether at a slot inception. The prongs are shaped and sized of aconfiguration and of a rigidity to substantially prevent deflection ofthe prongs. The prongs can include inwardly facing protrusions that areconfigured to capture and deform the connector between the protrusionsand prevent the connector from disengaging from the slotted anchordevice once engaged. The mechanism of suture attachment and strength ofthe assembly is a combination of compression of the suture between thestiff slotted prongs of the anchor as well as disruption of the suturesurface by the discreet edges of the slotted, flattened-tubular anchor.The discreet edges provide a lower contact surface area between anchorprongs and suture and focuses the compressive forces in focal pointsthat cause the suture to conform around both internal recesses andexternal faces. It is also to be recognized that various furtherembodiments of slotted anchors or anchors forming a clip are alsocontemplated. In particular, various embodiments of structures whichaccordingly provide alternative approaches to attach to a connector canbe employed. That is, the anchors can be deformable, deflectable,latching, nested, meltable and/or coiled in structure.

Accordingly, the present invention contemplates both pushing directly onanchor portions of an anchor assembly as well as pushing directly uponthe connector of the anchor assembly. Moreover, as presented above, thedistal or first anchor component is advanced and deployed through aneedle assembly and at least one component of the proximal or secondanchor component is advanced and deployed from a housing portion of theanchor deployment device. Further, either a single anchor assembly ormultiple anchor assemblies can be delivered and deployed at anintervention site by the deployment device. Additionally, a singleanchor assembly component can for example, be placed on one side of aprostate or urethra while multiple anchor assembly components can bepositioned along an opposite or displaced position of such anatomy. Thenumber and locations of the anchor assemblies can thus be equal and/orsymmetrical, different in number and asymmetrical, or simplyasymmetrically placed. In the context of prostate treatment, the presentinvention is used for the compression of the prostate gland and theopening of the prostatic urethra, the delivering of an implant at theinterventional site, and applying tension between ends of the implant.Moreover, drug delivery is both contemplated and described as a furtherremedy in BPH and over active bladder treatment as well as treatingprostate cancer and prostatitis.

Once implanted, the anchor assembly of the present inventionaccomplishes desired tissue manipulation, approximation, compression orretraction as well as cooperates with the target anatomy to provide anatraumatic support structure. In one preferred embodiment, the shape andcontour of the anchor assembly 700 is configured so that the assemblyinvaginates within target tissue, such as within natural folds formed inthe urethra by the opening of the urethra lumen by the anchor assembly(See FIGS. 71-72). In fact, in situations where the anchor assembly isproperly placed, wispy or pillowy tissue in the area collapses aroundthe anchor structure. Eventually, the natural tissue can grow over theanchor assembly 700 and new cell growth occurs over time (see FIG. 69).Such cooperation with target tissue facilitates healing and avoidsunwanted side effects such as calcification or infection at theinterventional site.

Subsequent to the interventional procedure, the patient can be directedto take alpha blockers for 2-4 weeks. Anti-inflammatory medicine canalso be taken.

Furthermore, in addition to an intention to cooperate with naturaltissue anatomy, the present invention also contemplates approaches toaccelerate healing or induce scarring. Manners in which healing can bepromoted can include employing abrasive materials, textured connectors,biologics and drugs.

It has been observed that placing the anchors at various desiredpositions within anatomy can extract the best results. For example, whentreating a prostate, one portion of an anchor assembly can be placedwithin an urethra and a second component beyond the outer surface of theprostate. It has been found that implanting the anchor assemblies byusing the distal end of the device to displace the prostate lobe oneither side (while the tension spring is taking up slack in theconnector after the delivery needle has been retracted) while deployingthe second anchor component so that the ten o'clock and two o'clockpositions (when looking along the axis of the urethra) are supported orretained, effectively holds the anatomy open and also facilitatesinvagination of the anchor portion within natural tissue. Typically, oneto two pairs of anchor assemblies are implanted to create an anteriorchannel along the urethra within the prostate gland (See FIG. 73). Thisis particularly true in the regions of anatomy near the bladder and thejuncture at which the ejaculatory duct connects to the urethra.

Additionally, it is contemplated that the components of the anchorassembly or selected portions thereof (of any of the anchor assembliesdescribed or contemplated), can be coated or embedded with therapeuticor diagnostic substances (e.g. drugs or therapeutic agents). Again, inthe context of treating a prostate gland, the anchor assembly can becoated or imbedded with substances such as 5-alpha-reductase which causethe prostate to decrease in size. Other substances contemplated includebut are not limited to phytochemicals generally, alpha-1a-adrenergicreceptor blocking agents, smooth muscle relaxants, and agents thatinhibit the conversion of testosterone to dihydrotestosterone. In oneparticular approach, the connector 95 can for example, be coated with apolymer matrix or gel coating which retains the therapeutic ordiagnostic substance and facilitates accomplishing the timed releasethereof. Additionally, it is contemplated that bacteriostatic coatingsas well as analgesics and antibiotics for prostatitis and other chemicalcoatings for cancer treatment, can be applied to various portions of theanchor assemblies described herein. Such coatings can have variousthicknesses or a specific thickness such that it along with theconnector itself matches the profile of a cylindrical portion of ananchor member affixed to the connector. Moreover, the co-delivery of atherapeutic or diagnostic gel or other substances through the implantdeployment device or another medical device (i.e. catheter), andmoreover an anchor assembly including the same, is within the scope ofthe present invention as is radio-loading devices (such as a capsular ordistal ends of implants for cancer or other treatment modalities). Inone such approach, the deployment device includes a reservoir holdingthe gel substance and through which an anchor device can be advance topick up a desired quantity of therapeutic or diagnostic gel substance.

It is to be recognized that the timing of the dual advancement of theneedle and connector assemblies and subsequent relative motion betweenthe assemblies is coordinated. That is, the needle assembly firstprovides access to an interventional site and then the connectorassembly is left extending beyond a terminal end of the needle assemblythrough the relative motion of the needle and connector assemblies.

It is further contemplated that in certain embodiments, the anchordelivery device can include the ability to detect forces being appliedthereby or other environmental conditions. Various sections of thedevice can include such devices and in one contemplated approach sensorscan be placed along the needle assembly. In this way, an operator candetect for example, whether the needle has breached the targetanatomical structure at the interventional site and the extent to whichsuch breaching has occurred. Other sensors which can detect particularenvironmental features can also be employed such as blood or otherchemical or constituent sensors. Moreover, one or more pressure sensorsor sensors providing feedback on the state of deployment of the anchorassembly during delivery or after implantation are contemplated. Forexample, tension or depth feedback can be monitored by these sensors.Further, such sensors can be incorporated into the anchor assemblyitself, other structure of the deployment device or in the anatomy.

Moreover, it is to be recognized that the foregoing procedure isreversible. In one approach, the connection of an anchor assembly can besevered and a proximal (or second) anchor component removed from thepatient's body. For example, the physician can cut the connector andsimultaneously remove the second anchor previously implanted forexample, in the patient's urethra using electrosurgical, surgical orlaser surgical devices used in performing transurethral prostateresection.

An aspect that the various embodiments of the present invention provideis the ability to deliver an anchor assembly having a customizablelength, each anchor assembly being implanted at a different locationwithout having to remove the device from the patient. Other aspects ofthe various embodiments of the present invention are load-baseddelivery, of an anchor assembly, anchor assembly delivery with a devicehaving integrated connector, (e.g. suture), cutting, and anchor assemblydelivery with an endoscope in the device. The delivery device isuniquely configured to hold the suture with tension during delivery tohelp ensure that the first anchor component sits firmly against a tissueplane (e.g., the outer capsule of the prostate) and is held relativelyfirm as the second anchor component is attached to the connector and thedelivery device. In this aspect, the needle assembly acting as apenetrating member is cooperatively connected to a mechanism which pullson the anchor while the needle assembly is retracted.

It is to be recognized that various materials are within the scope ofthe present invention for manufacturing the disclosed devices. Moreover,one or more components such as distal anchor, proximal anchor, andconnector, of the one or more anchor devices disclosed herein can becompletely or partially biodegradable or biofragmentable.

Further, as stated, the devices and methods disclosed herein can be usedto treat a variety of pathologies in a variety of lumens or organscomprising a cavity or a wall. Examples of such lumens or organsinclude, but are not limited to urethra, bowel, stomach, esophagus,trachea, bronchii, bronchial passageways, veins (e.g. for treatingvaricose veins or valvular insufficiency), arteries, lymphatic vessels,ureters, bladder, cardiac atria or ventricles, uterus, fallopian tubes,etc.

Finally, it is to be appreciated that the invention has been describedhereabove with reference to certain examples or embodiments of theinvention but that various additions, deletions, alterations andmodifications may be made to those examples and embodiments withoutdeparting from the intended spirit and scope of the invention. Forexample, any element or attribute of one embodiment or example may beincorporated into or used with another embodiment or example, unless todo so would render the embodiment or example unpatentable or unsuitablefor its intended use. Also, for example, where the steps of a method aredescribed or listed in a particular order, the order of such steps maybe changed unless to do so would render the method unpatentable orunsuitable for its intended use. All reasonable additions, deletions,modifications and alterations are to be considered equivalents of thedescribed examples and embodiments and are to be included within thescope of the following claims.

Thus, it will be apparent from the foregoing that, while particularforms of the invention have been illustrated and described, variousmodifications can be made without parting from the spirit and scope ofthe invention.

We claim:
 1. A system for treatment of body tissue, comprising: ananchor assembly, the anchor assembly including a first componentattached to a connector and a second component; and a delivery device,the delivery device including a needle assembly attached to a needlespool, a needle deploy actuator and a retract lever, a connector spooland a lever lock and tape; wherein the actuator accomplishes automateddeployment of the needle assembly and the lever accomplishes manualwithdrawal of the needle assembly; and wherein the lever lock and tapeincludes a body having a central axis coinciding with central turningaxes of the needle spool and connector spool, the lever lock and tapeconfigured to lock the lever and translate action of the lever to rotatethe needle assembly.
 2. The system of claim 1, wherein the deliverydevice includes a needle deployment spring and actuation of the needledeploy actuator results in the needle deployment spring turning theneedle spool and the connector spool to automatically advance the needleassembly with a force to penetrate through and beyond a prostate andouter capsule of the prostate.
 3. The system of claim 2, wherein thedelivery device includes a pawl controlling the rotation of theconnector spool relative to the needle spool.
 4. The system of claim 3,further including a tension spring configured about the connector spool,the tension spring applying tension to the connector.
 5. The system ofclaim 4, wherein the tension spring applies tension contemporaneouslywith independent rotation of the needle spool.
 6. The system of claim 5,wherein a tape portion of the lever lock and tape is attached directlyto the lever.
 7. The system of claim 6, wherein the needle assemblyhouses a first component of the anchor assembly.
 8. The system of claim7, wherein the system includes a second component of the anchorassembly.
 9. The system of claim 8, wherein a terminal end of the needleincludes a bevel defining a radius approximating a profile of theconnector.
 10. The system of claim 9, wherein actuators of the leverretracts the needle assembly farther than the needle can be advanced.11. The system of claim 10, wherein the delivery device includes asafety mechanism incorporated into the retract lever, the safetymechanism locking the needle deploy actuator.
 12. The system of claim11, further including an anchor assembly structure configured to effectassembly of the second component to the connector.
 13. The system ofclaim 12, further including a cutter assembly for severing of theconnector of the anchor assembly, the cutter including spacing structurefor ensuring a tag remains after severing the connector.
 14. The systemof claim 13, wherein the cutter assembly includes structure for aligningthe connector with the second component.
 15. The system of claim 14, thedelivery device further including a terminal end having one or moredirection or position indicators.
 16. The system of claim 15, furtherincluding an introducer sheath, wherein the delivery device includes asheath mount including a seal.
 17. The system of claim 16, furthercomprising a pusher assembly operatively associated with a thirdactuator, the pusher assembly including an extension for receiving thesecond component and for providing spacing to cut the connector.
 18. Thesystem of claim 17, wherein the cutter is operatively associated withthe third actuator.
 19. The system of claim 18, further comprising aninterlock for locking the third actuator.
 20. The system of claim 17,further comprising a spring for accomplishing longitudinal movement ofthe pusher and cutter.